510(k) K962582

OLYMPUS C4 IMMUNOTURBIDIMETRIC REAGENT by Olympus America, Inc. — Product Code DBI

K962582 is an FDA 510(k) premarket notification submitted by Olympus America, Inc. for the device "OLYMPUS C4 IMMUNOTURBIDIMETRIC REAGENT". The FDA issued a decision of Substantially Equivalent on October 18, 1996. The device falls under product code DBI (Complement C4, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5240. Olympus America, Inc. has at least 10 other 510(k) clearances on record.